Traditionally, many modern programmable medical devices, for example, medical infusion pumps, include internal memory for generating and storing data representing actual device operation over a period of time. The stored data may be reviewed from the medical device on a periodic basis by medical personnel, so that the subject's condition and treatment regimen can be closely monitored, and the medical device may be reprogrammed as needed. However, to retrieve data from certain prior medical devices, such as infusion pump, the subject would have been required to make regular visits to a medical treatment facility.
To overcome this drawback, raw data has been transferred from an infusion pump to another data storage and/or processing device. An example of a data transfer system for an infusion pump is disclosed in U.S. Pat. No. 5,376,070 issued Dec. 27, 1994 to Purvis et al. and is entitled “Data transfer System for an Infusion Pump,” which is herein incorporated by reference. This device relates to a relatively simple and effective data transfer system that is designed for retrieving data from, and sending program data to, a medication infusion pump. The data transfer system is particularly suited for remote data transfer and/or reprogramming of the infusion pump.
Another communication system for use with an infusion pump, analyte monitor, analyte meter or the like is described in published PCT application PCT/US99/22993. That system includes a communication station having a cradle for receiving a pump, meter or monitor, and for interfacing with a personal computer or the like. By connecting the pump, meter or monitor in communication with a personal computer, programming and instructions may be communicated from the computer to the medical device and data may be transferred from the medical device to the computer.
While some systems have been developed for retrieving subject information from a subject's medical device, there is a need in the industry for a more comprehensive system capable of collecting and managing subject information for multiple subjects, including multiple subjects with a plurality of different types of medical devices (different manufacturers, different models from the same manufacturer or different functional devices). There is also a need in the industry for such a system that provides capabilities for analyzing conglomerate data from multiple subjects, to develop or modify treatment plans for a particular subject or a group of subjects. There is a further need in the industry for such a system that allows a healthcare provider to issue a modifying treatment plan, for example, based on an algorithm or other scheme that determines a treatment modification based on subject information received from a particular subject or from a defined group of subjects. There is also a need in the industry for such a system that provides capabilities for complying (or showing compliance) with government regulations, industry standards or policies regarding, for example, security of personalized subject information, proper record keeping, automatic updating of user's software, and the like. There is yet a further need in the industry for a system that provides sufficient information to a healthcare provider, such as past subject information regarding a subject or group of subjects, to establish a starting point or initial settings for a new medical device that is about to be issued to a subject or group of subjects.